FearLess for Brain Cancer

Overseen By Mary Bridgman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cognitive impairment, Informed consent issues, Internet issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a psychological intervention called FearLess for individuals with primary malignant brain tumors and their caregivers. The goal is to assess the program's delivery and its effectiveness in reducing anxiety about cancer recurrence. Some participants will start the therapy immediately, while others will begin after a 12-week delay. It suits those who have undergone surgery or a biopsy for a brain tumor, feel anxious about cancer returning, and can attend virtual therapy sessions. As an unphased trial, it provides a unique opportunity to access innovative therapy that could alleviate cancer-related anxiety.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FearLess intervention is safe for primary malignant brain tumor patients and caregivers?

Research has shown that the FearLess program is a new and structured therapy, consisting of online sessions over 12 weeks. Although specific safety data from past studies is unavailable, therapies like FearLess are generally low-risk. They aim to improve mental health without using medications or physical treatments. As a form of talk therapy, major side effects are not anticipated. Many individuals find these therapies beneficial for emotional support and coping. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FearLess psychological intervention for neuro-oncology patients because it offers a fresh approach to managing fear and anxiety related to cancer. Unlike standard care options, which often rely on medication or general therapy, FearLess specifically targets the emotional challenges faced by those with neurological cancers through a tailored, manualized therapy. Delivered virtually over 12 weeks, it provides accessible, consistent support, potentially enhancing quality of life without the side effects of medication. This innovative focus on psychological resilience is what makes FearLess stand out as a promising new option.

What evidence suggests that the FearLess intervention is effective for primary malignant brain tumor patients and caregivers?

Research has shown that the FearLess program might help reduce anxiety and fear of cancer recurrence. In a small study, six children experienced significantly less anxiety, and their parents observed this improvement as well. The program employs well-known psychological techniques and includes eight online therapy sessions over 12 weeks. In this trial, participants in the FearLess Immediate Treatment Arm will begin the intervention immediately, while those in the FearLess Delayed Control Arm will start after a 12-week no-treatment period. Early results suggest it works well for patients with glioma, a type of brain tumor. Although more research is needed, the initial findings are encouraging for those dealing with cancer-related anxiety. ^{4 6 7 8 9}

Who Is on the Research Team?

Ashlee R Loughan, Ph.D

Principal Investigator

Virginia Commonwealth University

Sarah E Braun, Ph.D.

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

Inclusion Criteria

I often feel very worried about my cancer coming back.

I have been diagnosed with a grade II-IV primary brain tumor.

It has been more than 2 weeks since my brain surgery or biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants receive the FearLess psychological intervention immediately following enrollment, consisting of an intake and 8 weekly virtual therapy sessions over 12 weeks

12 weeks

9 virtual sessions

Delayed Treatment Control

Participants in the control arm undergo a 12-week no-treatment period before starting the FearLess intervention, which consists of an intake and 8 weekly virtual therapy sessions over 12 weeks

24 weeks

9 virtual sessions after 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FearLess in Neuro-Oncology

How Is the Trial Designed?

Group I: Fearless Immediate Treatment Arm Experimental Treatment 1 Intervention

FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. FearLess will be delivered immediately following enrollment in this arm.

Group II: FearLess Delayed Control Arm Experimental Treatment 1 Intervention

FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. In this arm, the FearLess intervention will begin following a 12-week no-treatment period.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Brain Tumor Society

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05604365

FearLess in Cognitively Intact Patients With Glioma This study will assess the preliminary feasibility and acceptability of FearLess, a newly-developed psychological intervention for fear of cancer recurrence ( ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jclp.23709

A case series evaluation of the Fearless Me! © program for ... Six children reported significant reductions in anxiety, with all showing significant reductions in parent-reported child anxiety at either ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06989086

Study Details | NCT06989086 | FearLess in NeuroOncology FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time ...

4. reporter.nih.gov reporter.nih.gov/search/0jZsL9e_kkS8iKhC34wzWw/project-details/10875094

Roybal Center for Fearless Behavior Change The goal of the Columbia Roybal Center for Fearless Behavior Change is to advance behavioral interventions that reduce psychological distress and improve ...

5. researchgate.net researchgate.net/publication/380843814_A_case_series_evaluation_of_the_Fearless_Me_C_program_for_children_with_intellectual_disabilities_and_anxiety

A case series evaluation of the Fearless Me! © program for ... They do not provide definitive evidence for effectiveness of psychosocial interventions ... treatment outcomes. However, little research has ...

6. fearlessorganizationscan.com fearlessorganizationscan.com/

Fearless Organization Scan The Fearless Organization Scan is a research-based survey tool designed to measure and improve psychological safety in teams.

7. fearlessorganizationscan.com fearlessorganizationscan.com/engage/free-personal-psychological-safety-survey

Free personal psychological safety survey A custom Fearless Organization Scan report for your organization gives leaders the data they need to strengthen psychological safety across departments, regions ...

8. mckinsey.com mckinsey.com/capabilities/people-and-organizational-performance/our-insights/psychological-safety-and-the-critical-role-of-leadership-development

Psychological safety and leadership development A new survey suggests how leaders, by developing specific skills, can create a safer and higher-performance work environment.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8685887/

A concept analysis of psychological safety - PubMed Central An analysis of 88 articles studying psychological safety in health care identified five attributes: perceptions of the consequences of taking interpersonal ...